Label: IYPOLY- immunoglobulin y aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 1, 2022

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  • Purposes

    Antiseptic

  • Active Ingredient

    Immunoglobulin Y 0.15%

    Citric Acid 0.01%

    Propylene glycol 1%

  • Uses

    Helps to prevent and reduce the penetration of respiratory infectious viruses.

  • Warnings

    Limit the use when hypersensitivity reactions occur due to the ingredients contained in this product.

  • Warnings

    Keep out of the reach of children

  • Warnings

    Do not share the bottle for hygienic reasons and to prevent the transmission of pathogens

  • Warnings

    Stop use if symptoms do not improve after using this product and consult a physician.

  • Warnings

    Please store this product at room temperature. (1~30 ℃ )

  • Directions

    Remove the protective cover and pump it a few times until it sprays evenly before the first use. Hold the body upright. Gently insert the tip of the device into the front part of the nose. Spray 1~2 times or required amount into the nose. After use, put the protective cover back on.

  • Inactive Ingredients

    Purified water , Pentyleneglycol , Methylparaben, Trehalose, Tannicacid , Citricacid,

    Sodiumcitrate, Propyleneglyco, PEG60 Hydrogenated, Casteroil , Greentea extract ,

    Sodiumcarbonate , Peppermint oil

  • Display Panel Label

    label

  • INGREDIENTS AND APPEARANCE
    IYPOLY 
    immunoglobulin y aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82462-103
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1 g  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.01 g  in 100 mL
    HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) HUMAN IMMUNOGLOBULIN G0.15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TANNIC ACID (UNII: 28F9E0DJY6)  
    PEPPERMINT OIL TERPENELESS (UNII: 4CA0UO1N3Z)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82462-103-0120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/23/2021
    Labeler - Whoniz (695574807)
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